# China NMPA Drug Inspection - Shandong Regen Pharmaceutical Co., Ltd - Metoprolol tartrate extended-release tablets

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/shandong-regen-pharmaceutical-co-ltd/297333d3-c847-402b-9bdb-1e1848729cd6/
Source feed: China

> China NMPA drug inspection for Shandong Regen Pharmaceutical Co., Ltd published November 18, 2019. Drug: Metoprolol tartrate extended-release tablets. The Shandong Provincial Food and Drug Administration announced on June 15, 2017, findings from quality sampling inspecti

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## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: Announcement from Shandong Provincial Food and Drug Administration Regarding 8 Batches of Substandard Drugs in Quality Spot Checks (Issue 4, 2017)
- Company Name: Shandong Regen Pharmaceutical Co., Ltd
- Publication Date: 2019-11-18
- Drug Name: Metoprolol tartrate extended-release tablets
- Inspection Finding: examine
- Action Taken: The relevant municipal food and drug administrations have taken control measures such as sealing, seizing, suspending sales, and recalling the substandard drugs, and have investigated or are investigating the manufacturers and sampled units in accordance with relevant laws and regulations.
- Summary: The Shandong Provincial Food and Drug Administration announced on June 15, 2017, findings from quality sampling inspections that revealed eight batches of substandard drugs. These inspections, conducted by five testing institutions, identified issues with products from both medical institutions and commercial pharmaceutical companies. 

Companies implicated include Jinan Fifth People's Hospital, Shandong Provincial Acupuncture Hospital, Dongjia Orthopedic Clinic, Jilin Changheng Pharmaceutical Co., Ltd., Shandong Renhetang Pharmaceutical Co., Ltd., Linzhou Yashen Pharmaceutical Co., Ltd., and Shandong Liangfu Pharmaceutical Co., Ltd. Main violations encompassed critical quality parameters such as minimum filling, physical properties, weight uniformity, identification, dissolution rates, presence of visible foreign matter, and active ingredient content, indicating failures to meet established drug quality standards. 

The regulatory framework for these assessments included the "Shandong Provincial Medical Institution Preparation Standards" and various editions of the "Chinese Pharmacopoeia." In response, municipal food and drug administration bureaus took immediate control measures, including sealing, seizing, suspending sales, and recalling the non-compliant drugs. Ongoing investigations into the responsible manufacturers and sampled units are mandated. Furthermore, regulatory bodies are required to enhance daily supervision, urge enterprises to investigate root causes, develop and implement rectification measures, and eliminate potential risks to public health.

Company: https://www.globalkeysolutions.net/companies/shandong-regen-pharmaceutical-co-ltd/1d6ab961-9488-46f3-874d-7e0ff99054a1/